Official recall record
DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination w (ref Z-2455-2024)
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2024-06-05
- Country of alert
- Japan
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 14987666545065
- Brand on record
- Beckman Coulter Mishima K.K.
- Product category
- Medical Device
What the authority reported
There are two software bug issues with the analyzer. Issue 1: When a dedicated rack is reserved for calibration, after a calibration test has been placed and completed, the same rack may be used to place both a patient order and a calibration order. When a patient sample and a non-barcoded calibrator tube is processed on the rack, the calibration result will be reported as a patient result. Issue 2: calibration with expired calibrator. They both may cause erroneous patient results, but the probability of serious adverse health consequences or death is unlikely.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.
Same barcode in other registries
The same EAN appears in 1 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.
- 2024-07-10 · US FDA — Medical Devices
DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in sampl
Other recalls from this brand
- 2026-08-03 · US FDA — Medical Devices
Systems/units containing affected software/SQL BECKMAN COULTER CHEMISTRY ANALYZER AU480 REF / UDI-DI code: - 2026-01-30 · US FDA — Medical Devices
CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281 - 2026-01-30 · US FDA — Medical Devices
DxC 700 AU, REF: B86444, B86446